Expandable devices and methods for tissue expansion, regeneration and fixation

ABSTRACT

Expandable devices and methods for treating and enlarging a tissue, an organ or a cavity. The device is composed of a hollow expanding pouch made of a resorbable material or a perforated material that can be attached to a filling element. The pouch can be filled with a biocompatible materials, one or more times in few days interval, after the insertion of the device. While filling the pouch every few days the tissue expands and the filling material if it is bioactive start to function. The devices allow immediate direct contact between the filling material and the tissue. These devices and methods can be used for example for: horizontal and vertical bone augmentation in the jaws, soft tissue augmentation, fixating bone fractures etc.

This application is a Continuation-in-Part of PCT/IL2003/000951 filedNov. 12, 2003, which claims priority from U.S. Ser. No. 10/291,477 filedNov. 12, 2002, pending.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to an improved methods and devices fortreating and healing a tissue deficiency or pathology in a living humanor animal body. The methods and the devices combine a mechanical actionand a biological action.

For example, the present invention can be used for guided boneregeneration in the jaws as part of dental treatment with dentalimplants. It can be used to fixate bones, to fill bone cavities and toexpand bone cavities.

The present invention consists of an expansion device that can include abioresorbable film or a perforated film and a method for tissueregeneration. In order to clarify the principles of the presentinvention the following description will focus on two implementations:bone regeneration in the jaws preceding dental treatment with dentalimplants, and fixating bone fractures. The same principles may beapplied to other tissues and other organs and other areas of the body.

Treatment of edentulous patients with osseointegrated fixtures made oftitanium is a well known procedure in the art. The procedure includesinstalling a fixture in the alveolar bone of an at least partiallyedentulous jaw. Usually several months are required for proper healingafter fixture installation.

After healing, an abutment is installed on the upper portion of thefixture. After several weeks, an artificial tooth may be mounted on theabutment and the procedure is complete.

Installation of implants requires sufficient alveolar bone, generallyabout 10 mm height and 6 mm width.

When a tooth is removed, the alveolar bone is gradually resorbed becauseof the absence of stimulus of ossification-inducing pressure from theteeth. As the resorption process advances, the size of the bone getsreduced, i.e. the bone on which the dental roots are positioned—thealveolar ridge starts shrinking.

The absence of just one tooth can cause modifications throughout thedental arch and even prompt a possible softening (loss of insertion)which may cause the loss of other teeth. The absence of several teethaggravates the problem. Bone loss may finally modify the patient'sappearance and, depending on the loss, may make him incapable ofreceiving bridges, implants or even dentures.

It is then necessary to carry out several surgical operations toreconstruct the alveolar ridge of the maxilla or mandible.

Although these methods of surgical reconstruction have been successfullyperformed, this type of operation has had drawbacks. Certain methodshave involved opening the mucoperiosteal tissue along the entire lengthof the atrophic alveolar ridge and then placing a bone graft materialand a membrane on top of the graft and then suturing the delicatemucoperiosteal tissue back together to cover the membrane. The role ofthe membrane is to maintain the bone graft in its place and to preventthe mucoepithelium from growing into the graft and interfering with theprocess of bone regeneration. This surgical operation has had drawbacksbecause it is difficult to stretch and cover the augmented ridgeresulting in high prevalence of membrane exposure and infection.

The present invention is unique because it simultaneously regeneratesthe soft and the hard tissues, therefore avoids most of the foregoingdrawbacks and permits a more simplified and effective means for boneregeneration:

This invention relates also to methods and devices for correcting boneabnormalities and involves use of an inflatable device, which can beinserted into a prepared cavity in bone or to be adjacent bones. Thedevice is inflated using bone replacement material to expand and fillthe cavity. The device can be inserted subperiostealy to enlarge thebone.

U.S. Pat. Nos. 5,108,404 and 4,969,888 to Scholten et al. describe asystem for fixing osteoporotic bone using an inflatable balloon, whichcompacts the bone to form a cavity into which bone cement is injectedafter the balloon is withdrawn. The invention requires the use offluoroscopy to monitor the injection and to help guard against cementleakage through fissures in bone. Unfortunately, such leakage is knownto occur in spite of these precautions. Since such leakage may causeserious injury, including paralysis, an improved device and method isneeded. U.S. Pat. No. 5,972,015 to Scribner et al. describes a system ofdeploying a catheter tube into the interior of a vertebra and expandinga specially configured nonporous balloon there within to compactcancellous bone to form a cavity. The Scribner U.S. Pat. No. 5,972,015approach utilizes a non-porous balloon which is inflated within the boneto cause compression. The cavity thus formed may then be filled withbone cement. Unfortunately, the bag used by Scribner may be rupturedduring expansion to compact cancellous bone due to sharp projectionsfound within the cavity to be expanded. Filling the cavity eventuallyformed could allow leakage of bone cement out of the bone againstvessels or nerves which may cause undesirable complications.

U.S. Pat. Nos. 5,549,679 and 5,571,189 to Kuslich describe a device andmethod for stabilizing the spinal segment with an expandable, porousfabric implant for insertion into the interior of a reamed out discwhich is packed with material to facilitate bony fusion. The device ofKuslich prevents direct contact between the filled material and thebone. In the present invention, an improved device is used to correctbone abnormalities including, but not limited to, bone tumors and cysts,tibial plateau fractures, avascular necrosis of the femoral head andcompression fractures of the spine.

The present invention involves an improvement of all of the previoustechniques and avoids complications that could occur with the system ofU.S. Pat. No. 5,972,015. Therefore, it is an object of this invention toprovide a method and apparatus that has some or all of these properties.

SUMMARY OF THE INVENTION

The present invention provides a method and device by which, as thedevice is enlarged, a space is created to allow tissue ingrowth. Thespace created can be filled with a biocompatible material. Theenlargement and filling can be done simultaneously and the filling canbe the cause for the expansion of the device. The biocompatible materialcan be a bioactive material like a drug or an inert material.

The device is made of a pouch or compartment that can be filledpreferably through a filling element with the biocompatible material.The pouch is made fully or partially of a bioresorbable material or aperforated material and it acts like a balloon that expands as it isfilled with the biocompatible material. The pouch preferably has atleast one region that allows tissue ingrowth or immediate direct contactbetween the filled material and the surrounding tissue and at least oneregion that prevents contact between the filled material and thesurrounding tissue. The region that allows the contact can be perforatedwith a large hole or several holes of several hundreds of microns or canbe a completely open region or wall. The filling material preferablyincludes rigid particles or material which becomes rigid so the directand immediate contact results in continuous mass of material extendingfrom the internal space of the device to the tissue. In the presentinvention a space in the body is created by the expandable or inflatabledevice. This space is preferably filled with a biocompatible/bioactivematerial. The expansion of the expandable device can be by the fillingwith biocompatible material like bone cement. The device is preferablyconfigured to allow the filling. The space filled with the fillingmaterial is not isolated from the tissue so part of the filling materialis touching the tissue. This contact is by passing through the big holesor touching the tissue in a region of the device that is completelyopen. Part of the material is released through walls of the device sothe material touching the tissue and the material inside the device areforming one continuous substance. There are prior art devices that allowdiffusion of drugs through their walls. These devices have pores ofseveral nanometers and the molecules passing the wall are not formingone mass of material with the materials inside the device. If thematerial is Bioresorbable then tissue can grow and replace the fillingmaterial resulting in a new space in the body filled with the newtissue. Using a bioresorbable filling material will result in tissueregeneration. For bone regeneration the filling material preferably isbone augmenting material which occupy a space in the body for severalmonths. The filling material to allow expansion by inflation preferablyis suspension of particles or cement or material with high viscosity.Most bone augmenting materials available today are particles or viscousgels or cements or combinations. The size of the holes can be determinedby the size of the particles in the filling material or the degree ofthe viscosity of the filling material.

The pouch is filled one or more times every few days till the desiredenlargement is reached. While the pouch expands it conducts tensileforces to the surrounding tissues which reacts in proliferation andenlargement. At the same time more biocompatible materials can be added.After the desired enlargement is reached the filling element can bepulled out if necessary. If the device is made from bioresorbablematerials there is no need to take out the device. The end result is anew or enlarged compartment in the body filled with regenerated tissueand/or a biocompatible material.

The basic principle is to create a cavity into which tissue from acontrolled direction is growing inside the cavity or to insert insidethe body a biocompatible material to a predetermined location in apredetermined geometry and to allow contact between the tissue and thebiocompatible material which preferably is bioactive. The fillingmaterial preferably is highly viscous, particulated or becomes rigidinside the body. The fact that there are holes of several dozens orseveral hundreds of microns allows the material to pass and to touch thesurrounding tissue and to create one high viscous or rigid substanceconnecting the internal space created by the device and the tissue. Thisfeature distinguishes the present invention from other inflatabledevices that prevent direct contact between the internal space and theexternal space. There are devices that permit drug delivery through theenvelop of the inflatable device but there is no inflatable device likethe present devices that allow the immediate formation of a continuousmass of materials extending from the inside of the device to the tissue.

The insertion of the device can be through a small incision to a tunnelso all the process is done with almost no surgery.

There are many possible implementations of the device and methoddepending on several factors:

-   -   1. The place the device is inserted into.    -   2. The filling material.    -   3. The shape of the pouch.    -   4. The kind of filling element that is in use.    -   5. The kind of material the pouch is made of.

The device and method can be therefore used for selective regenerationof more or less specialized tissues, for example, membranes demarcatingbody cavities and/or separating different tissues and organs from eachother, as well as, for selective regeneration of different tissueswithin the organs, or the organs themselves in relation to thesurrounding tissues or nerves. Examples of membranes are the periosteum,the membranes of the brain and the peritoneal membrane; while examplesof organs are the bones, bone cavities, liver, the throat, theventricle, the kidney, the heart and the pancreas. Also, muscle tissuetendons, fat tissue, vessels, ducts, and tubes should be possible toregenerate with this device and method.

The device and method are particularly useful for plastic surgery,dental implantology, orthopedics and in cardiac surgery. In plasticsurgery it can be used for soft tissue enlargement like lips and breastsand for facial bones enlargement. In dental implantology it can be usedfor horizontal and vertical augmentation of the alveolar ridge when thepouch is placed beneath the periosteum and for sinus augmentation whenthe pouch is placed beneath the Schneiderian membrane preceding theplacement of dental implants. In orthopedics for fixating fractures andfor minimal invasive delivering of bone regenerating materials to thegap between bone fragments.

The invention provides a method of correcting numerous boneabnormalities including bone tumors and cysts, avascular necrosis of thefemoral head, tibial plateau fractures and compression fractures of thespine. The abnormality may be corrected by first accessing and boringinto the damaged tissue or bone and reaming out the damaged and/ordiseased area using any of the presently accepted procedures or thedamaged area may be prepared by expanding a device within the damagedbone to compact cancellous bone. After removal and/or compaction of thedamaged tissue the bone must be stabilized. In cases in which the boneis to be compacted, the methods and devices of this invention employ acatheter tube attached to an inflatable device. This device may beinflated with less fear of puncture and leakage of the inflation mediumthan thin walled rubber balloons. They may also be used over a Scribnerballoon to protect the balloon from breakage and eventually seepage. Thedevice additionally provide the surgeon with the advantage of safelyskipping the first balloon inflation steps of Scribner and Scholten, byexpanding the device through introduction of filling material, such as abone repair medium thereby correcting the bony defect and deformity andstabilizing it in one step of the procedure The device preferably hasone region that allows direct contact between the bone and the fillingmaterial to improve stabilization and another region that preventsdirect contact and leakage of the filling material. As indicated above,the damaged bone may be removed by any conventional reamer. Examples ofreamers are know and may be used. After the damaged bone or tissue hasbeen removed, bone repair medium may then be inserted into the cavity.Alternatively, either a smaller than desired cavity may be formed intothe bone to be enlarged by compaction or the cavity may be formed onlyby compaction through introduction of filling material into the device.In either case, the device may be positioned over the inflation balloonwhich is then inflated within the bone site to provide the degree ofcompaction required. The device may then be filled with fillingmaterial, such as bone repair medium while the balloon remains in placewithin the device. Alternatively, the balloon may be removed from thedevice prior to filling the bag.

Other objects and features of the present invention will become apparentin the following detailed description when taken in connection with theaccompanying drawings which disclose one embodiment of the invention. Itis to be understood that the drawings are designed for the purpose ofillustration only and are not intended as a definition of the limits ofthe invention.

Thus, according to the teachings of the present invention there isprovided, a method for expanding, stretching or displacing living tissuecomprising: (a) inserting into the tissue an inflatable element made atleast in part from bio-dissipative material; (b) introducing into theinflatable element a quantity of a biocompatible filling material so asto displace the tissue; and (c) leaving at least part of the inflatableelement in place for a period sufficient to allow the bio-dissipativematerial to disperse.

According to a further feature of the present invention, the introducingis performed in a plurality of stages separated by at least a number ofhours, each stage incrementally stretching the tissue.

According to a further feature of the present invention, thebiocompatible filling material includes a bio-active material.

According to a further feature of the present invention, thebiocompatible filling material includes material for promoting thegrowth of at least one type of tissue.

According to a further feature of the present invention, the inflatableelement is located beneath the Schneiderian membrane of the maxillarysinus or of the nose.

According to a further feature of the present invention, the insertingis performed such that the inflatable element is located substantiallyat a bone-soft tissue interface, the biocompatible filling materialincluding material for promoting the growth of bone such that,subsequent to dispersal of the inflatable element, the biocompatiblefilling material promotes extension of the bone beyond the initialbone-soft tissue interface.

According to a further feature of the present invention, the materialfor promoting the growth of bone includes at least one material selectedfrom the group made up of: an autograft, an allograft, a xenograft, analloplast, a cytokine, a hormone, a growth factor, a physiologicallyacceptable drug, a biological modifier, a protein, an antigen, a cellchemotaxis stimulator material, a material inducing osteogenesis, anosteoinduction material, and an osteoconduction material.

According to a further feature of the present invention, the inflatableelement includes a guided bone regeneration membrane located so as to beadjacent to the soft tissue.

According to a further feature of the present invention, the inflatableelement is configured to have a first region which exhibits a first meantime to dispersion and a second region which exhibits a second mean timeto dispersion longer than the first mean time to dispersion.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a stretchable material.

According to a further feature of the present invention, the inflatableelement is formed from more than one type of material.

According to a further feature of the present invention, the inflatableelement is configured to have a first portion with a first stiffness anda second portion with a second stiffness differing from the firststiffness.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a material which serves as aselective barrier configured to allow at least a first material totraverse the barrier while preventing passage of at least a secondmaterial.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a self-expanding material.

According to a further feature of the present invention, thebiocompatible filling material includes a self-expanding material.

According to a further feature of the present invention, the introducingis performed via a filling conduit partially inserted into the tissue.

According to a further feature of the present invention, the fillingconduit is formed at least partially from non-bio-dissipative material.

According to a further feature of the present invention, the fillingconduit includes a sealing means for sealing the filling conduit afterthe introducing of the biocompatible filling material.

According to a further feature of the present invention, disinfectingmaterial is introduced into the filling conduit after the introducing ofthe biocompatible filling material.

According to a further feature of the present invention, the fillingconduit is implemented as a bone implant.

According to a further feature of the present invention, the fillingconduit is formed with at least one fixation feature.

According to a further feature of the present invention, the introducingis by temporarily puncturing the inflatable element with a needleinserted through the tissue, the inflatable element being configured tobe self-sealing on removal of the needle.

According to a further feature of the present invention, prior toinserting the inflatable element, a tunnel is formed into the tissue forinsertion of the inflatable element.

According to a further feature of the present invention, prior toinserting the inflatable element, a plurality of shallow, elongatedincisions are formed in the tissue adjacent to the tunnel so as tofacilitate stretching of the tissue.

According to a further feature of the present invention, the shallowelongated incisions are formed manually by moving an elongated tool withat least one laterally projecting blade in a reciprocating motion withinthe tunnel.

According to a further feature of the present invention, the elongatedtool is configured to produce incisions of depth no greater than about 2mm.

According to a further feature of the present invention, the elongatedtool is configured to produce incisions of depth between about 0.1 mmand about 1 mm.

According to a further feature of the present invention, the inflatableelement is configured to apply outward force on a substantiallycylindrical living tissue without completely obstructing a flow pathwhich passes within the substantially cylindrical living tissue.

According to a further feature of the present invention, the inflatableelement is configured as a double-walled sleeve.

There is also provided according to the teachings of the presentinvention, a device for expanding, stretching or displacing livingtissue comprising: (a) an inflatable element for insertion into thetissue, the inflatable element being made at least in part frombio-dissipative material; and (b) means for introducing into theinflatable element a quantity of a biocompatible filling material so asto displace the tissue.

According to a further feature of the present invention, the inflatableelement is configured to have a first region which exhibits a first meantime to dispersion and a second region which exhibits a second mean timeto dispersion longer than the first mean time to dispersion.

According to a further feature of the present invention, the inflatableelement includes a guided bone regeneration membrane.

According to a further feature of the present invention, the inflatableelement is formed from a plurality of types of material.

According to a further feature of the present invention, the inflatableelement is configured to have a first portion with a first stiffness anda second portion with a second stiffness differing from the firststiffness.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a material which serves as aselective barrier configured to allow at least a first material totraverse the barrier while preventing passage of at least a secondmaterial.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a self-expanding material.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a stretchable material.

According to a further feature of the present invention, the means forinflating includes a filling conduit configured for inserting into thetissue so as to be accessible from outside the tissue, the fillingconduit being formed with at least one fixation feature configured toallow fixation of the conduit relative to the tissue.

According to a further feature of the present invention, the fillingconduit is formed at least in part from non-bio-dissipative material.

According to a further feature of the present invention, the fillingconduit includes a sealing means.

According to a further feature of the present invention, the fillingconduit includes a chamber for receiving disinfectant material.

According to a further feature of the present invention, the fillingconduit is implemented as a bone implant.

According to a further feature of the present invention, the means forintroducing includes a hollow needle configured to pierce part of theinflatable element for filling, the inflatable element being configuredto reseal itself after withdrawal of the needle.

According to a further feature of the present invention, the inflatableelement is configured to apply outward force on a substantiallycylindrical living tissue without completely obstructing a flow pathwhich passes within the substantially cylindrical living tissue.

According to a further feature of the present invention, the inflatableelement is configured as a double-walled sleeve.

There is also provided according to the teachings of the presentinvention, an elongated tool for forming shallow elongated incisions inliving tissue adjacent to a tunnel formed through the tissue so as tofacilitate stretching of the tissue, the tool comprising: (a) a handle;(b) an elongated shaft associated with the handle, the elongated shafthaving a direction of elongation, a maximum transverse dimensionmeasured perpendicular to the direction of elongation and a lengthmeasured parallel to the direction of elongation, wherein the maximumtransverse dimension is at least about 3 mm and wherein the length is atleast five times the maximum transverse dimension; and (c) at least oneblade projecting from the elongated shaft and configured to formincisions of depth no greater than 2 mm in adjacent tissue when the toolis inserted within the tunnel and moved parallel to the direction ofelongation.

According to a further feature of the present invention, the length isat least about ten times the maximum transverse dimension.

According to a further feature of the present invention, the maximumtransverse dimension is between about 5 mm and about 10 mm.

According to a further feature of the present invention, the at leastone blade is configured to form incisions of depth between about 0.1 mmand about 1 mm.

There is also provided according to the teachings of the presentinvention a method for expanding, stretching, displacing or fixatingliving tissue comprising: (a) inserting into the tissue an inflatableelement, the inflatable element includes at least one not-sealed regionbeing configured after being filled with a biocompatible material toenable contact between the tissue and the biocompatible material; and(b) introducing into the inflatable element a quantity of abiocompatible filling material, the introducing being performed in aplurality of stages separated by at least a number of hours.

Thus, according to the teachings of the present invention there isprovided, a method for expanding, stretching, displacing, fixating ortreating living tissue comprising:

-   -   inserting into the tissue an expandable element, the expandable        element includes at least one soft pliable region, the        expandable element being configured to allow filling with a        biocompatible material so as to enable immediate direct contact        between the tissue and the biocompatible filling material so as        to create a continues mass of the biocompatible filling material        connecting the tissue with the space created by the expandable        device; and expanding the expandable element.

According to a further feature of the present invention the expandingbeing performed in a plurality of stages separated by at least a numberof hours.

According to a further feature of the present invention thebiocompatible filling material is highly viscous and configured tooccupy the space for at least several months.

According to a further feature of the present invention thebiocompatible filling material includes rigid particles and configuredto occupy the space for at least several months.

According to a further feature of the present invention the expandingbeing performed in a plurality of stages separated by at least a numberof hours.

According to a further feature of the present invention the methodincludes insertion of a biocompatible filling material through theexpandable element.

According to a further feature of the present invention the insertion ofthe biocompatible filling material is expanding the expandable element.

According to a further feature of the present invention the expandableelement is made at least in part from bio-dissipative material.

According to a further feature of the present invention the expandableelement has one region which prevents contact between the said tissueand said biocompatible filling material.

According to a further feature of the present invention the introducingis displacing the tissue.

According to a further feature of the present invention the expandableelement has a first region with a first resistance to passage of a givenmaterial and a second region with a second resistance to passage of thegiven material, the second resistance being less than the firstresistance.

According to a further feature of the present invention the givenmaterial includes cells and blood vessels.

According to a further feature of the present invention thebiocompatible filling material includes a bio-active material.

According to a further feature of the present invention the inserting isperformed such that the expandable element is located substantially at abone-soft tissue interface, the biocompatible filling material includingmaterial for promoting the growth of bone such that, subsequent to thecontact of the biocompatible filling material with the tissue thematerial for promoting the growth of bone promotes extension of the bonebeyond the initial bone-soft tissue interface.

According to a further feature of the present invention the expandableelement is configured to have a first region which exhibits a first meantime to dispersion and a second region which exhibits a second mean timeto dispersion longer than the first mean time to dispersion.

According to a further feature of the present invention the introducingis performed via a filling conduit partially inserted into the tissue.

According to a further feature of the present invention the fillingconduit is implemented as a bone implant.

According to a further feature of the present invention the expandableelement is configured to take a specific shape as the expandable elementis filled and to resist changes in the shape of the expandable elementas a result of forces coming from outside the expandable element.

According to a further feature of the present invention the expandableelement is configured to grow in a telescopic pattern.

According to a further feature of the present invention the expandableelement includes a component assisting in the enlargement of theexpandable element.

According to a further feature of the present invention the expandableelement includes at least one region having a first stiffness and asecond region having a second stiffness less than the first stiffness soas to define a direction of expansion of the expandable element.

According to a further feature of the present invention the expandableelement is closed by being attached to at least one surface of thetissue such that the expandable element becomes inflatable after beingattached to the tissue.

According to a further feature of the present invention the expandableelement is placed beneath the gums.

According to a further feature of the present invention the expandableelement includes a rigid element facing the gums, the rigid elementbeing attached to a non rigid element configured so as to grow in atelescopic pattern, the rigid element includes at least one tube beingconfigured to protrude through the gums to the oral cavity, the tubebeing configured to be sealed with a sealing component.

According to a further feature of the present invention the expandableelement includes mechanical mechanism configured to allow displacementof the rigid element from the bone so as to displace the gums.

According to a further feature of the present invention the mechanicalmechanism is connected to a dental implant configured to support adental prosthesis.

According to a further feature of the present invention the mechanicalmechanism includes a stabilizing component to prevent micro-motion ofthe rigid element.

According to a further feature of the present invention the non rigidelement is a guided bone regeneration membrane.

According to a further feature of the present invention the expandableelement includes at least one elevating screw configured to allowdisplacement of the rigid element from the bone so as to displace thegums.

According to a further feature of the present invention the expandableelement includes at least one elevating nut configured to be threaded onthe elevating screw, the elevating nut being configured to be accessiblethrough the tube, the elevating nut being configured to touch the rigidelement so as turning the elevating nut results in displacement of therigid element.

According to a further feature of the present invention the elevatingscrew is hollow and perforated so as to allow insertion of boneaugmenting material through the upper region of the elevating screwinside the space of the expandable element, the upper region of theelevating screw being configured to be accessible through the tube.

According to a further feature of the present invention the elevatingscrew is a dental implant configured to support a dental prosthesis.

According to a further feature of the present invention the tube isconfigured to be detached from the rigid element leaving a hole in therigid element, the hole being wide enough to allow replacement of theelevating screw with a bone implant through the hole, the bone implantbeing connected to the rigid element by a stabilizing element, thestabilizing element includes one region configured to be threaded to theinternal threads of the bone implant and a second region configured tobe threaded to threads in the rigid element around the hole, thestabilizing element is configured to seal the hole.

According to a further feature of the present invention the expandableelement is inserted inside the breast and said biocompatible fillingmaterial is fat cells.

According to a further feature of the present invention the fat cell aresucked from another region in the body.

According to a further feature of the present invention the expandableelement being configured after being filled with a setting biocompatiblefilling material to fixate the tissue as the setting biocompatiblefilling material sets; and introducing into the expandable element aquantity of a setting biocompatible filling material.

There is also provided according to the teachings of the presentinvention a method for expanding, stretching, displacing or fixatingliving tissue comprising: (a) inserting into the tissue an inflatableelement made having a first region which is perforated so as to allowpenetration of cells and blood vessels and a second region which isresistant to ingrowth of tissue; and (b) introducing into the inflatableelement a quantity of a biocompatible filling material so as to displacethe tissue.

According to a further feature of the present invention the inflatableelement is made at least in part from bio-dissipative material.

According to a further feature of the present invention the introducingis performed in a plurality of stages separated by at least a number ofhours, each stage incrementally stretching the tissue.

According to a further feature of the present invention thebiocompatible filling material includes a bio-active material.

According to a further feature of the present invention thebiocompatible filling material includes material for promoting thegrowth of at least one type of tissue.

According to a further feature of the present invention the inflatableelement is located beneath the Schneiderian membrane of the maxillarysinus or of the nose.

According to a further feature of the present invention the inflatableelement having one region that can be detached from the inflatableelement and taken out of the tissue after filling of the inflatableelement so as to enable direct contact between the biocompatible fillingmaterial and the tissue.

There is also provided according to the teachings of the presentinvention method for expanding, stretching, displacing or fixatingliving tissue comprising: (a) inserting into the tissue an inflatableelement, the inflatable element being configured after being filled witha setting biocompatible filling material to fixate the tissue as thesetting biocompatible filling material sets; and (b) introducing intothe inflatable element a quantity of a setting biocompatible fillingmaterial.

According to a further feature of the present invention the inflatableelement is made at least in part from bio-dissipative material.

According to a further feature of the present invention the inflatableelement has a first region with a first resistance to passage of a givenmaterial and a second region with a second resistance to passage of thegiven material less than the first resistance.

According to a further feature of the present invention the inflatableelement is configured to take a specific shape as the inflatable elementis filled and to resist changes in the shape of the inflatable elementas a result of forces coming from outside the inflatable element.

According to a further feature of the present invention the inflatableelement is configured so as to enable contact between the tissue and thesetting biocompatible filling material.

According to a further feature of the present invention the inflatableelement is configured to fix two tissue fragments in given spatialrelation.

According to a further feature of the present invention whereininflatable element has a first region which is perforated to allow notdamaging leakage of the biocompatible filling material and a secondregion which is resistant to leakage of the biocompatible fillingmaterial.

According to a further feature of the present invention the first regionis facing bone and the second region is facing other tissues.

According to a further feature of the present invention the inflatableelement is inserted into a space inside bone.

According to a further feature of the present invention the inflatableelement is inserted between two bone fragments.

According to a further feature of the present invention the inflatableelement is inserted into a crushed vertebra.

According to a further feature of the present invention the introducingis displacing the tissue.

According to a further feature of the present invention the introducingis displacing the fragments of the crushed vertebra.

There is also provided according to the teachings of the presentinvention a device for expanding, stretching, displacing or fixatingliving tissue comprising: (a) an inflatable element for insertion intothe tissue, the inflatable element includes at least one not-sealedregion being configured after being filled with a biocompatible materialto enable contact between the tissue and the biocompatible material; and(b) means for introducing configured to be accessible from outside thetissue and to allow filling of the inflatable element several times, themeans for introducing including sealing means configured to seal themeans for introducing.

There is also provided according to the teachings of the presentinvention a device for expanding, stretching, displacing or fixatingliving tissue comprising:

-   -   an expandable element for insertion into the tissue, the        expandable element includes at least one soft pliable region,        the expandable element being configured to allow filling with a        biocompatible material so as to enable immediate direct contact        between the tissue and the biocompatible filling material so as        to create a continues mass of the biocompatible filling material        connecting the tissue with the space created by the expandable        device.

According to a further feature of the present invention the expandableelement has

-   -   means for introducing configured to be accessible from outside        the tissue and to allow filling of the expandable element        several times, the means for introducing including sealing means        configured to seal the means for introducing.

According to a further feature of the present invention the expandableelement is made at least in part from bio-dissipative material.

According to a further feature of the present invention the expandableelement has a first region with a first resistance to passage of a givenmaterial and a second region with a second resistance to passage of thegiven material less than the first resistance.

According to a further feature of the present invention the expandableelement is configured to take a specific shape as the expandable elementis filled and to prevent changes in the shape of the expandable elementas a result of forces coming from outside the expandable element.

According to a further feature of the present invention the expandableelement is configured to grow in a telescopic pattern.

According to a further feature of the present invention the expandableelement includes a component assisting in the enlargement of theexpandable element.

According to a further feature of the present invention the expandableelement is configured to be closed by being attached to at least onesurface of the tissue such that the expandable element becomesinflatable after being attached to the tissue.

According to a further feature of the present invention the expandableelement is configured to have a first region which exhibits a first meantime to dispersion and a second region which exhibits a second mean timeto dispersion longer than the first mean time to dispersion.

According to a further feature of the present invention the means forintroducing is a filling conduit.

According to a further feature of the present invention the fillingconduit is implemented as a bone implant.

According to a further feature of the present invention the expandableelement includes at least one region having a first stiffness and asecond region having a second stiffness less than the first stiffness soas to define a direction of expansion of the expandable element.

According to a further feature of the present invention the expandableelement is formed at least in part from a material which serves as aselective barrier configured to allow at least a first material totraverse the barrier while preventing passage of at least a secondmaterial.

According to a further feature of the present invention the expandableelement is formed with at least one fixation feature.

According to a further feature of the present invention the fillingconduit includes a chamber for receiving disinfectant material.

According to a further feature of the present invention the expandableelement includes a rigid element, the rigid element being attached to anon rigid element configured so as to grow in a telescopic pattern, therigid element includes at least one tube being configured to protrudethrough the gums to the oral cavity, the tube being configured to besealed with a sealing component.

According to a further feature of the present invention the expandableelement includes mechanical mechanism configured to allow displacementof the rigid element.

According to a further feature of the present invention the mechanicalmechanism includes a stabilizing component to prevent micro-motion ofthe rigid element.

According to a further feature of the present invention the mechanicalmechanism is configured to be connected to a dental implant configuredto support a dental prosthesis.

According to a further feature of the present invention the non rigidelement is a guided bone regeneration membrane.

According to a further feature of the present invention the expandableelement includes at least one elevating screw configured to allowdisplacement of the rigid element.

According to a further feature of the present invention the expandableelement includes at least one elevating nut configured to be threaded onthe elevating screw, the elevating nut being configured to be accessiblethrough the tube, the elevating nut being configured to touch the rigidelement so as turning the elevating nut results in displacement of therigid element.

According to a further feature of the present invention the elevatingscrew is hollow and perforated so as to allow insertion of boneaugmenting material through the upper region of the elevating screwinside the space of the expandable element, the upper region of theelevating screw being configured to be accessible through the tube.

According to a further feature of the present invention the elevatingscrew is a dental implant configured to support a dental prosthesis.

According to a further feature of the present invention the tube isconfigured to be detached from the rigid element leaving a hole in therigid element, the hole being wide enough to allow replacement of theelevating screw with a bone implant through the hole, the bone implantbeing connected to the rigid element by a stabilizing element, thestabilizing element includes one region configured to be threaded to theinternal threads of the bone implant and a second region configured tobe threaded to threads in the rigid element around the hole, thestabilizing element is configured to seal the hole.

There is also provided according to the teachings of the presentinvention a device for expanding, stretching, displacing or fixatingliving tissue comprising: an inflatable element configured after beingfilled with a setting biocompatible filling material to fixate thetissue as the setting biocompatible filling material sets; and means forintroducing into the inflatable element a quantity of the settingbiocompatible filling material.

According to a further feature of the present invention the inflatableelement is made at least in part from bio-dissipative material.

According to a further feature of the present invention the inflatableelement having a first region with a first resistance to passage of agiven material and a second region with a second resistance to passageof the given material less than the first resistance.

According to a further feature of the present invention the inflatableelement is configured to take a specific shape as the inflatable elementis filled and to resist changes in the shape of the inflatable elementas a result of forces coming from outside the inflatable element.

According to a further feature of the present invention the inflatableelement is configured so as to enable contact between the tissue and thesetting biocompatible filling material.

According to a further feature of the present invention wherein theinflatable element is configured to fix two tissue fragments in givenspatial relation.

According to a further feature of the present invention whereininflatable element has a first region which is perforated to allow notdamaging leakage of the setting biocompatible filling material and asecond region which is resistant to leakage of the setting biocompatiblefilling material.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIG. 1 is a perspective view illustrating the novel device used inaccordance with the invention to receive and contain bone augmentationmaterial. In this preferred embodiment the filling element is a cannula.

FIG. 2 is a perspective view illustrating the device of FIG. 1 After itwas filled with bone augmenting material.

FIG. 3 is a bottom view illustrating the device of FIG. 2.

FIG. 4 is a sectional view of the device in a telescopic configuration.

FIG. 5A is a perspective view illustrating the novel device used inaccordance with the invention made from a rigid plate connected to aflexible sheet.

FIG. 5B is a perspective view of the device of FIG. 5A when the sheet isfolded vertically.

FIG. 5C is a perspective view of the device of FIG. 5A when the sheet isfolded horizontally.

FIG. 6 is a sectional view of the device of FIG. 5A that includes aperforated hollow screw and an elevating nut to displace the plate fromthe bone.

FIG. 7 is a sectional view of the device of FIG. 6 to illustrate the useof two elevating screws and nuts.

FIG. 8 is a perspective view illustrating the novel device used withaccordance with the invention wherein the device of FIG. 5 is used withan external elevating screw.

FIG. 9 is a sectional view illustrating the connection between the plateand a dental implant inserted at an early stage.

FIG. 10A is a sectional view illustrating the elevating abutment, whichis part of the elevating mechanism.

FIG. 10B is side view of the plate and the tubes.

FIG. 10C is a sectional view of the dental implant.

FIG. 10D is a sectional view of the hollow screw, which is part of theelevating mechanism.

FIG. 10E is a sectional view of the nut, which is part of the elevatingmechanism.

FIG. 10F is a sectional view of the fixating screw, which is part of theelevating mechanism.

FIG. 11 is a sectional view of the plate of FIG. 10B in thebucco-lingual aspect.

FIG. 12 is a perspective view of the plate of FIG. 10B.

FIG. 13A is a side view of the device after placement subperiostealy.

FIG. 13B is a side view of the device of FIG. 13A at the end of theperiosteal distraction.

FIG. 13C is a side view of the device of FIG. 13A after replacement ofthe elevating mechanism with the stabilizing mechanism.

FIG. 14 is a side view illustrating a crushed vertebra.

FIG. 15 is sectional view illustrated the novel device inside thecrushed vertebra.

FIG. 16 is a sectional view illustrating the device inside the vertebrafrom above.

FIG. 17 is a perspective view illustrating the device for externalfixation of long bones.

FIG. 18 is a sectional view illustrating the device for internalfixation of long bones.

FIG. 19 is side view of the femur joint with a fracture.

FIG. 20 is a sectional view illustrating the novel device inside the hipof FIG. 19.

FIG. 21 is a sectional view illustrating the device going through a discbetween adjacent vertebras.

FIG. 22A is a sectional view illustrating the novel device for cementingartificial joints.

FIG. 22B is a sectional view of the hip stem of the artificial joint.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As mentioned further above there are many implementations of theinvention in different tissues and organs. The following descriptionwill focus on embodiments in two fields in order to understand theprinciples of the device and method. The first is bone augmentation inthe jaws the second is fixating bone fragments. The same principlesshould be used in other tissues and organs.

Before turning to the features of the present invention in more detail,it will be useful to clarify certain terminology as will be used hereinin the description and claims. Specifically, it should be noted that thepresent invention is useful in a wide range of applications in whichliving tissue is to be expanded, stretched, fixated or displaced. Theterm “living tissue” is used herein to refer to any living tissueincluding, but not limited to, an organ, tube, vessel, cavity, bonecavity or membrane, and interfaces between any two or more of the above.Where used within a single type of tissue, the typical application ofthe present invention is for expanding the tissue. When used at a tissueinterface, the invention is typically used to displace one of the typesof tissue, in many cases for the purpose of expanding/extending theother tissue. The invention may also be used to increase the innerdimensions of tubes, vessels cavities or bone cavities within the body.

In another matter of terminology, it is noted that a large number ofdifferent types of materials are known which may be inserted within thebody during a surgical procedure and which later dissipate, therebyavoiding the need for a separate surgical procedure for their removal.Such materials are properly referred to, depending upon the mechanism bywhich the material dissipates, as “bioresorbable”, “bioabsorbable” or“biodegradable”. Despite the differences between these different classesof materials, the aforementioned terminology is widely usedinterchangeably by medical professionals. Accordingly, and forconciseness of presentation, only one of these terms will generally beused in the following description, without implying the exclusion of theother classes of materials. Additionally, the phrase “bio-dissipativematerial” is used herein in the description and claims to refergenerically to any and all materials which dissipate without requiringsurgical removal, independent of which mechanisms such as dissolution,degradation, absorption and excretion take place. The actual choice ofwhich type of materials to use may readily be made by one ordinarilyskilled in the art, and is not generally essential to the presentinvention.

Finally with respect to terminology, reference will be made to abiocompatible filling material used to fill the inflatable elements ofthe present invention. It should be noted that this filling material mayassume a wide range of compositions and consistencies, so long as thebiocompatible material may be forced into the inflatable element. Thus,possible consistencies for the filling material include, but are notlimited to, consistencies described as watery, viscous, gelatinous,moldable, waxen, particulate, and suspensions or mixtures combining anyof the above.

Turning now in detail to the drawings, which depict the presentlypreferred embodiments of the invention for the purpose of illustratingthe practice thereof and not by way of limitation of the scope of theinvention, and in which like reference characters refer to correspondingelements throughout the several views.

FIG. 1, illustrates the novel device embodying the present invention foruse in bone reconstruction and, in particular, for augmentation ofatrophic alveolar ridges. The device is composed of a pouch 5. The pouchcan be made from autograft, allograft, xenograft and alloplast andcombination thereof. The pouch is made from a biocompatible material.Preferably, the pouch is made at least in part from resorbable materialsto prevent a chronic foreign body reaction like: conventionallyavailable polyglycolic acid (PGA) mesh, a high-molecular-weight linearpolymer made by the ring opening polymerization of the purifiedglycolide monomer, although other suitable materials might be used e.g.polyglactin 910, i.e. polyglycolide co-galactide. In addition, collagenor PDS (another absorbable suture material) or cellulose might possiblyalso be used as a pouch material. The pouch can be perforated all overto allow tissue ingrowth and some degree of leakage of the fillingmaterial. The size of pores depend on the filling material, preferablythe size of the pores are several hundreds of microns and even severalmillimeters. The pouch preferably has a porous region preferably towardsthe bone to allow bone tissue ingrowth and preferably has a region thatblocks epithelial tissue ingrowth. The pouch preferably allows somefilling material to get out of the pouch under pressure through theperforated region. Expanding a perforated pouch can be done withparticulated filling material. Most bone augmenting materials areavailable as particles in the size of 200-2000 microns. To allow easyinsertion preferably the particles are mixed with a solution likesaline, blood or biocompatible gels like cellulose, glycerol andhydrogel. If the size of the pores in the pouch are 1.5-5 times greaterthan the particles size the pouch can be inflated. Some particles canget out of the pouch but no massive leakage can occur. Preferably thepores are 3 times the particles size. This feature allows inflation ofthe pouch with minor leakage and immediate direct contact between thefilling material and the bone with no danger for massive or damagingleakage. The perforated pouch can be also inflated using a high viscousgel like Dinagraft which is gelatinous allograft bone augmentingmaterial or with bone cements like PMMA. The end result is onecontinuous mass of the filling material which is rigid or highly viscousconnecting the tissue and the internal space of the device for at leastseveral months.

The pouch 5 is connected to a conduit in the shape of a cannula 6. Theconduit can be also catheter, valve, bone implant, syringe andcombination thereof. Bone implant can be hollow bone implant, slottedbone implant, threaded implant, cylinder implant, smooth surfaceimplant, titanium plasma sprayed implant, hydroxyapatite coated implant,acid etched surface implant, sand blasted surface implant, S.L.A.surface implant, ceramic implant, zirconium implant and any combinationthereof.

The conduit is made of a biocompatible material and can be made frommore then one type of material bioresorbable or non-bioresorbable.Preferably the cannula is made of commercially pure titanium or titaniumalloy used in the dental implant industry. The cannula is connected tothe pouch in one side and in the other side it can be filled and closedwith a screw 7 as a sealing component. Sealing components can be also avalve, a clamping element, a knot and combination thereof. The conduitcan have variable shapes, dimensions, cross section and elasticity Thecannula 6 has preferably fixating components in order to prevent thecannula from moving, get out and cause uncomfortable filling to thepatient. The a fixation component can be selected from the groupconsisting of hook, hole for sutures, slot, thread, bulge, screw, changein dimension, irregularity and any combination thereof.

In this preferred embodiment there are three fixating component. Onefixating component is a slot 8 that is near the pouch and inserted intothe body. After the tissue heals around the slot it prevent the cannulafrom getting out easily. The other two fixating components are holes forsutures 9 that are near the sealing screw 7 and not inserted into thebody. After the insertion of the device the pouch can be filled withbone augmenting material causing the wrinkled and compressed pouch 5 toexpands and become a filled pouch 10 in FIG. 3.

The pouch can be made of more than one type of material. Preferably thepouch is composed of two types of resorbable materials. One type that israpidly resorbed and allows bone ingrowth and the second type that isslowly resorbed and prevent the ingrowth of epithelial tissue. It canalso be made as illustrated in FIG. 3 of one type that is perforated 11allowing contact between the filling material and the bone and thesecond type 12 preventing direct contact and leakage of the fillingmaterial. The perforated region preferably has pores that allows thefilling material to get outside the pouch to wet the external surface ofthe pouch but prevents leakage of the filling material. The size of thepores are dependent on the filling material. For PMMA cement the poresize are in the range of 0.05-0.5 mm depending on the viscosity of thecement. When inserting the pouch the rapidly resorbed material or theperforated material 11 should face the bone. The perforated region canhave one or several macro holes of several dozens of microns or to haveone or several big holes of several millimeters. The end result is acontinues rigid mass of cement connected to the tissue and going insidethe device.

The slowly resorbed material 12 can be also not resorbable material likeePTFE if in this case the gums are going to be open when placing thedental implants and then the not resorbable material can be taken out.

The pouch can include also self expanding components. Materials include,either alone or in combination, metals or metal alloys, polymers, carbonand ceramics. Exemplary metallic members include stainless steel,titanium, tantalum, shape-memory materials such as nickel-titanium alloy(NiTi) (Compounds using NiTi are manufactured under the marks NITINOL™and ELASTINITE™ and are available from several sources), Elgiloy (tradename) and NP35N (trade designation), which can provide desired degree ofspringiness, malleability and/or response to temperature changes.Exemplary polymers include polyurethanes, silicon rubbers, polyether,sulfones, fluoroelastomers, polyimides, polycarbonates, polyethylens,polylactic acid, polyglycolic acid, polyacrylates, and the like andcombinations and copolymers thereof which provide a variety of abilitiesto bioabsorb or biodegrade or to be totally inert. The pouch can includesprings and coils that are compressed before insertion and can includestretchable and elastic materials for example polyurethanes likepolycarbonate urethane.

In another preferred embodiment the pouch can include materials withdifferent degree of stiffness. The material facing the bone can be lessstiff than the material facing the gums.

The combination of several regions with different degree of stiffnesscan influence the direction of enlargement of the pouch and also theshape of the filled pouch. The pouch can have variable shapes and thevolumes according to the use. For example to reconstruct the entire jawthe pouch will be elongated in C-shape and filling element will beattached in the middle.

In another preferred embodiment the inflatable element can be configuredto expand in a pre designed direction and take a specific shape as it isbeing filled. For example the inflatable element can be designed in atelescopic configuration as illustrated if FIG. 4. The inflatableelement can be made from a stiff small container 61, that it's open sideis facing the bone 62 located inside a larger stiff container 63 thatit's open side is facing the gums 64, between the walls of thecontainers one 65 or several small walls can be also. The base 66 of thebigger container that is touching the bone is preferably made from astiff bioresorbable material like polylactic acid, the rest of theinflatable element can be made also from bioresorbable materials or fromnon-resorbable biocompatible materials like titanium. The basepreferably is perforated to allow the filling material to touch thebone. The diameter of the container and the walls in the region facingthe bone is larger then the diameter in the opposite side. Thereforewhen pushing the small container upwards towards the gums till it'slower region will reach the upper region of the adjacent wall it willpull the adjacent wall upwards. Each wall in this way will pull the nextwall resulting in a higher and a bigger compartment with a pre designedshape.

In another preferred embodiment the device of FIG. 4 can be without abase and the bone becomes the base of the device. In this embodiment thedevice becomes inflatable after placing over the bone and fixating tothe bone. The device can be made from non resorbable materials liketitanium.

In another preferred embodiment the perforated pouch can be covered by arigid structure with a pre designed form so when the pouch is filled itwill take the form of the rigid structure. In another embodiment therigid structure can be place over the gums so when the pouch beneath thegums is filled the pouch and the gums will take the shape of the rigidstructure.

In another preferred embodiment the pouch also includes a selectivebarrier that permits transfer of some cells and materials and preventsthe transfer of other cells and materials. Therefore allowing boneforming cells and blood to get inside the pouch and block the entranceof connective tissue cells. This barrier can also permit the release ofmedication mixed with the filling material without letting the fillingmaterial to leak. This barrier should be adopted for its specific usefor example to have little holes, sized according to the medicine to bereleased.

In another preferred embodiment the inflatable element can include amechanical component that assists in the enlargement of the device. Themechanical component can include a screw that its activation enlargesthe device. After the device was enlarged a biocompatible material likebone augmenting material can be inserted into the space created byenlarging the device. The tissue is displaced by activating themechanical component and the filling of the device plays a minor role inthe displacement of the tissue or no role at all. These embodimentsutilizing the mechanical component are especially useful for verticalridge augmentation. There are several options of using this principle.In one embodiment the device of FIG. 4 includes an elevating screw thatis entering through the upper region of the small container 61 andengages threads in the upper region of the container. The screw touchesthe base of the container 66. The screw protrudes through the gums sowhen the screw is activated the small container is displaced and thedevice is enlarged. The space can be filled with a bone augmentingmaterial by using a filling conduit. The filling conduit can protrudefrom the upper region of the device. In this embodiment the upper regionhas two protrusions one the screw and the other the filling conduit. Ina preferred embodiment the screw can be also the filling conduit. Inthis preferred embodiment the screw is hollow and perforated andconfigured to allow insertion of bone augmenting material. In apreferred embodiment the screw is turned and filling is donesimultaneously by using a special syringe that can also rotate thescrew. In a preferred embodiment the screw is a bone implant. In all thecases described in this application when a screw is mentioned itincludes also the possibility of being a bone implant or a dentalimplant. If the screw is a bone implant it has significant advantageover a regular screw that there is no need for later insertion of boneimplants therefore saving for the patients another surgical procedureand the time of the treatment is reduced. In another preferredembodiment the device has no base as mentioned before and the fillingmaterial is touching the bone. In this embodiment the elevating screw istouching the bone. In this embodiment drilling a hole in the bone forthe tip of the elevating screw is recommended. In another embodiment asmall base implant can be inserted to the bone. This base implant has aninternal hole configured to stabilize the tip of the elevating screw. Inthis embodiment the elevating screw doesn't touch the bone, thereforeactivating the screw cause no pain to the patient. In this embodiment asmentioned before the screw can be a bone implant or dental implant andalso hollow and also perforated and function also as the fillingconduit.

In another preferred embodiment illustrated in FIG. 5A the device ismade from two parts the upper part facing the gums 80 is a plate 81 madefrom a rigid material like titanium or a rigid bio-dissipative materialand a membrane 82 that is attached around the plate 81. The membrane 82preferably forms a substantially conical structure. The small diameterof the cone is attached to the plate 81 and the large diameter isconfigured to be attached to the bone 83. The membrane 82 can beattached to bone by little screws or bone tacks 84. The membrane can beperforated at the edge near the bone so after placement of the deviceand suturing the periosteum, the periosteum adhere to the bone throughthe holes 85 in the membrane so the membrane 82 becomes attached to thebone 83. The membrane 82 is preferably folded at the beginning so therigid plate 81 is placed close to the bone. When the device is enlargedthe folds are opened and the plate 81 is displaced from the bone. Theenlargement can be by filling the device through a tube 86 that isconnected to the plate 81. The tube has preferably a sealing screw 87.The enlargement can be by using an elevating screw as described above.The use of a membrane 82 as the telescopic element instead of a rigidstructure as described in FIG. 4 enables to fit easily the device todifferent architectures of bones. The membrane can be a guided boneregeneration membrane and can be bio-dissipative. The folds of themembrane can be in the vertical dimension as in FIG. 5B or in thehorizontal dimension as in FIG. 5C and in any configuration that allowsfor enlargement of the device. Another advantage of the use of amembrane is that the elevating screw allows vertical enlargement anddisplacement of the gums and the filling of the device allows forhorizontal enlargement and displacement of the gums.

The meaning of the term rigid all over the application is that the plateis more rigid than rubber or cloth like material. Preferably even morerigid than the periosteal tissue therefore the shape of the periostealtissue is dictated by the shape of the rigid plate. The plate can becompletely rigid like metal or semi rigid like plastic.

Another important feature of the device is to prevent micro-motion ofthe plate. In case of distraction osteogenesis and fracture healingmicro-motion is known to accelerate the healing. In the embodiments ofthe present invention micro-motion of the plate will createfibrocapsular reaction and will prevent bone regeneration. The devicesknown for distraction osteogenesis which are based on screws can notprevent micro-motion. The micro-motion preferably should be less than 50micrometers. The following devices must include a stabilizing element toprevent micro-motion. The distraction mechanism by itself as it is inosteogenesis distractors can not prevent micro-motion. This innovativefeature is critical for the success of the device.

Another preferred embodiment is illustrated in FIG. 6. FIG. 6 is asectional view of the device after placement on the bone 97 and beingfilled with bone augmenting material 98. The elevating screw 90 isfixated to the bone 97 and an elevating nut 91 is threaded on theelevating screw. The elevating nut is configured to displace the upperplate 92 and consequently unfold the folded membrane 99 that is attachedto the plate as described in FIG. 5. In this embodiment the screw 90helps also in stabilizing the plate 92 and in controlling the directionof enlargement. The screw 90 as mentioned can be hollow 93 andperforated 94 and can be a bone implant or a dental implant. In theembodiments that the screw is configured to be the bone implant, it isrecommended that the screw will not be in direct contact with the oralenvironment, in order to keep the properties of the surface of the boneimplant. In these embodiments the plate can include a tube 95 that canbe sealed with a sealing cup 96. The elevating screw 90 is placed in thespace of the tube 95 and activating the nut 91 is done through the tube95. Filling the device can be through the screw 90 if it is hollow orthrough another opening in the plate. In another preferred embodimentillustrated in FIG. 7 a device like the device of FIG. 6 has more thenone elevating screw. FIG. 7 is a side view of the device after removalof the membrane. The plate 100 is like the plate 92 of FIG. 6 but ismore elongated. There are two elevating screws 101, two nuts (one isillustrated 102), two tubes 103, two sealing cups 104. This embodimentis recommended for the augmentation of edentulous ridge 105. The use ofmore then one elevating screw 101 improves the stabilization of thedevice and prevents the rotation of the upper plate 100 when activatingthe elevating nuts 102. It is recommended that the tubes 103 are made oftitanium. The screws 101 are preferably hollow and perforated. Thescrews are inserted by using a parallelism guide. After the screws 101are inserted the nuts 102 are placed over the screws and threaded to beadjacent the bone 105. Then the plate 100 is placed over the screws 101and nuts 102 and the folded membrane is attached to the bone 105. Thetubes 103 can be sealed by using sealing cups 104. The sealing cups 104can be threaded to the tubes 103 if the tubes 103 have threads in theirupper region. Preferably the sealing cups 104 are threaded to theelevating screws 101 so they can function as a stabilizing element toprevent micro-motion of the plate. At the beginning the sealing cups 104are high and should be replaced with lower cups as the device isenlarged. It is recommended to enlarge vertically the device at a rateof 1 mm per day. In each enlargement filling of the device with boneaugmenting material can be done. It can be done simultaneously or thefilling is done after the mechanical enlargement or before themechanical enlargement. The filling preferably can be done after theplate is distracted to the final position so there is only one procedureof filling. The enlargement of the devices described here and above canbe done in several steps or continuously over a period of several hoursor days. The continuous manner can include a pump for continuous fillingof the device and a mechanical or electrical component that exertsforces for a long period of time. After the device has reached its finaldimension and it is filled with bone augmenting material, it is possibleto add bio-active materials into the device even several weeks andmonths later. Bio-active material can be Bone Morphogenic Proteins(B.M.P) that accelerates the regeneration of bone or can be antibioticsin case of infection.

In another preferred embodiment the screws are regular dental implantsthat are not perforated and the filling is done through another openingor through the gap between the tube and the elevating screw. In thisembodiment the tube is the filling conduit. The plate can be elevatedabout 1 mm above the regular dental implants to allow filling with thebone augmenting material in the gap between the dental implants and theplate.

In another preferred embodiment illustrated in FIG. 8 the elevatingscrew 107 can be placed outside the device as it is in externaldistractors. A base element 108 is fixated to the bone outside theregion of the device. The plate 110 includes a lateral projection 109outside the gums 116 and the elevating screw 107 passes through theprojection 109 to the base element 108. When the screw 107 is activated,the plate 110 is displaced from the bone 111, the membrane 112 isunfolded and bone augmenting material can be inserted into the devicethrough the tube 113. The membrane is fixated to the bone by screws ortacks 114 or by holes in the membrane 115 as described in FIG. 5A. Theadvantage of this device is that there is no screw in the region wherebone is to be regenerated, therefore the rate of success is expected tobe higher.

In another preferred embodiment the plate is configured to allowreplacement of the elevating screw with the final bone implant withouttaking the device out. In this embodiment the bone implant can beinserted in an early phase and shorten the treatment time. The elevatingscrew is preferably narrow in order not to interfere with the process ofbone regeneration and to reduce the hole in the gums. The final boneimplant is preferably wide in order to have more surface attached to thebone. Therefore it is recommended to replace the elevating screw, whichcan be also perforated and hollow with a final bone implant or dentalimplant The replacement can be done after the device has reached itsfinal dimension and the filling is complete. The tube in this embodimentis threaded to the plate and they are not one piece. The hole in theplate after removing the tube should be at least 3.8 mm to allow theinsertion of a regular 3.75 mm dental implant. After the tube is removedfrom the plate the elevating screw is taken out through the hole in theplate and the final dental implant is inserted instead. FIG. 9illustrates a sectional view of the device after the insertion of thefinal bone implant and before closing the hole in the plate. After thefinal dental implant 120 is inserted to the bone 121 a cover screw 122is screwed inside the dental implant 120 (in the preferred case of animplant with an internal thread) and engaged the threads 123 in the holeof the plate 124. In this state, dental implant 120 stabilizes the plate124. The cover screw 122 has one region 125 with threads that arecompatible with the internal threads of the dental implant and a secondregion 126 that the threads fits the threads 123 of the hole in theplate and a region 127 that seals the connection between the plate andthe cover screw. In this configuration for every dental implant in themarket a special cover screw can be developed. After the insertion ofthe dental implant and the cover screw the bone is regenerated aroundthe dental implant because the dental implant is surrounded by boneaugmenting material 128 that is closed in the space created by themembrane 129. The process of osseointegration of the implant occurssimultaneously with the regeneration of the bone therefore the treatmentis shorter.

In another preferred embodiment the plate described in the embodimentsabove is a rigid mesh and a bio-dissipative membrane is attached to themesh and closes the holes of the mesh. The advantage of thisconfiguration is that the plate with the mesh allows the filling of thedevice and prevents connective tissue to enter the space where bone isexpected to regenerate, but after the membrane is resorbed blood vesselscan enter from the periosteum and supply the new bone.

In all the embodiments where the titanium plate was mentioned connectedto a membrane FIG. 5, 6, 7, 8, 9 the plate can be connected preferablyto a perforated membrane that allows blood vessels to enter the cavityand give nutrition to the regenerating bone. In this embodiment theplate is preferably perforated like a titanium mesh with pore size of0.2-1 mm. The device can be made only from the titanium plate without amembrane. As the titanium plate is distracted from the bone a cavity iscreated between the plate and the bone. This cavity can be filled withbone augmenting materials through the filling tubes. When the device hasno membrane the holes in the plate can be even larger at the range of0.5-2 mm. The filling can be done after each distraction or at the endwhen the plate reaches the final position.

The device can be sold to the dental surgeon connected to the membraneor without a membrane. In case the device is not connected to themembrane it allows the dental surgeon to choose the appropriatemembrane. In this preferred embodiment the plate preferably includesholes or slots to allow the suturing of a membrane to the plate or toallow the connection of the membrane by clamps to the plate.

The devices described above being made from a plate and tubes arepreferably sold to the dental surgeon separately and the dental surgeonis connecting them. This preferred embodiment is useful for insertion ofthe device in the tunnel technique. The surgeon first creates thesubperiosteal tunnel then inserts the plate that can be connected to themembrane inside the tunnel. Perforates the gums above the device andconnecting the tubes through the perforation to the device. Theconnection can be by screwing or bonding. The insertion of the platewithout the tubes allows to insert the device to a lower tunnel which ismore easy to perform and prevents tearing of the gums in the process ofmaking the tunnel and in the insertion of the device.

In another preferred embodiment illustrated in FIG. 10 the use ofregular dental implants 131 (FIG. 10C) and stabilizing elevatingmechanism is implemented. Elevating abutments 138 (FIG. 10A) arethreaded to the implants 131 through the tubes 132 of the plate 133illustrated in FIG. 10B. The elevating abutments 138 have a slimextending rod 134 and a wider stop 135. The extending rods 134 haveinternal threads 136. Rings 140 with internal threads 141, externalthreads 142 and circular sealing edge 143 are threaded to the tubes 132.Hollow screws 145 (FIG. 10D) are threaded to the internal threads of therings 141 till they touch the wider stop 135 of the elevating abutment138. The hollow screws 145 have a wider diameter hollow space at theirupper region 146. The extending rods 134 are inside the small diameterspace 147 of the hollow screws 145. Nuts 150 (FIG. 10E) are threadedover the hollow screws till they touch the rings 140. Locking screws 155(FIG. 10F) are threaded to the internal threads 136 of the extendingrods 134 till they touch the stop 157 in the hollow screws.

In this embodiment the plate is stabilized to prevent micro-motion. Thelocking screws 155 fixate the hollow screws 135 to the elevatingabutments 138. The elevating abutments 138 are fixated to the dentalimplants 131 which are fixated to the bone. The nuts 150 are fixatingthe hollow screws 145 to the rings 140 which are fixated to the tubes132 of the plate 133. When distraction of the plate 133 is needed thenuts 150 are unscrewed about 1 mm from the rings 140, the locking screws155 are unscrewed to release the fixation of the hollow screws 145 andthe hollow screws 145 are rotated. Since the hollow screws 145 aretouching the wider stop 135 of the elevating abutments 138 the hollowscrews 145 can't move towards the dental implants 131 so they areelevating the rings 140 which are threaded to the hollow screws 145. Therings 140 which are fixated to the tubes 132 of the plate 133 thereforeelevate the plate 133. The plate 133 is elevated till the rings 140touch the nuts 150. The plate 133 preferably is curved and not flat soit can fit the alveolar ridge, which is usually not flat. When the plateis intended to fit the alveolar ridge of the mouth the plate is curvedin the bucco-lingual plane as can be seen in FIG. 11. FIG. 11 is asectional view of the device placed in the jaws. The plate 133 is curvedto fit the bone 160 of the alveolar ridge. The gums 161 are covering theplate and the tube 132 is protruding through the gums 161. The spacebetween the plate 133 and the bone at the insertion of the device ispreferably as small as possible to eliminate the need to stretch thegums. A curved plate allows good fitting of the device to the bone. FIG.12 is a perspective view of the device demonstrating the curved plate133 and the tubes 132. The plate preferably has some small holes 163 onits edge to allow suturing of a membrane around the plate as it isillustrated for the plates of FIG. 5, 6, 8, 9. The plate preferably hasslots 165 at the connection between the tubes 132 and the plate 133 toincrease the space between the plate and the dental implant tofacilitate the insertion of bone substitute material. The slots 165allow the insertion of bone substitute materials without significantelevation of the plate above the dental implant therefore the stretchingof the gums is reduced and number of elevating sessions is reduced.

FIG. 13 illustrates the assembling of all the parts of FIG. 10 withoutthe membrane. The device has two tubes 132 and it is placed on twodental implants 131. For illustrating the assembling the right side ofthe device is showing perspective view and the left side a sectionalview. FIG. 13A illustrates the device after insertion before the processof gradual distraction of the gums 161. The plate is at the bone level170, the rings 140 are screwed to the tubes 132, the hollow screws 145are screwed to the rings 140 over the extending rods 134. The plate isbelow the gums 161 and above the bone level touching the bone. The tubes132 are protruding through the gums to the oral cavity. The fact thatthe tubes are part of the plate and are moving with the plate allows touse short tubes that can fit to all cases. The nuts 150 are screwed overthe hollow screws 145 till they touch the rings 150 to preventmicro-motion between the plate and the hollow screws. The locking screws155 are fixating the hollow screw 145 to the extending rods 134therefore the device is fixated to the dental implants 131 and to thebone and micro-motion is prevented between the plate and the bone. FIG.13B is illustrating the device at the end of the elevating process. Aspace is created between the plate 133 and the bone that can be filledwith bone augmenting material. The filling can be after each elevationor at the end. After filling the space preferably the elevationmechanism can be replaced with a stabilizing mechanism. The parts of theelevating mechanism to be replaced are the elevating rods 138, thehollows screws 145, the nuts 150 and the locking screws 155. Thestabilizing mechanism is illustrated in FIG. 13C. The stabilizingmechanism includes a stabilizing abutments 172 that are screwed to thedental implants 131. The stabilizing abutments 172 have internal threadsin their upper region to fit the fixating screws 173. The fixatingscrews 173 are fixating the rings 140 to the stabilizing abutments 172and therefore stabilize the plate 133 and prevents micro-motion. Thestabilizing mechanism is also a sealing mechanism to prevent theentrance of infection through the tubes to the space below the plate.

In another preferred embodiment there is no need for the elevatingabutment. The hollow screw is seated over the dental implant and fixatedto the implant by a fixating screw in the same way abutments are fixatedto dental implants. (The hollow screw has internal narrower region closeto the region which is adjacent the implant and the head of the fixatingscrew is wider than this narrow region, so when the fixating screw isscrewed through the hollow screw inside the dental implant the hollowscrew is fixated to the implant.) The hollow screw has no antirotational element in its contact region with the implant to allow therotation of the screw and therefore the distraction of the plate fromthe bone. In order to allow the rotation of the hollow screw thefixating screw and the stabilizing nut has to be released.

It is important that the plate will not have sharp edges and to haveslopes 175 between the tubes and the plate borders. Rounded borders andslopes will prevent perforations of the gums and exposure of the plateto the oral cavity. The plate can be in the shape of a circular cone oroval cone in the preferred embodiment of one plate over one dentalimplant. The surface of the plate can be different at different regionof the plate. The region of the plate facing the bone preferably arerough to allow good adhesion of the blood clot for example S.L.A surfaceof Straumann, Osseotite surface of 3I, Tiunite of Branemark or HAsurface. The region of the plate facing the gums are preferably alsorough like the plate or rough to a limited degree to allow good adhesionof the periosteal tissue to the plate in order to prevent slipping ofthe tissue while distracting the device. The surface of the plate nearthe tubes and the tubes in one preferred embodiment are smooth or acidetched to prevent plaque accumulation. In another preferred embodimentthe surface of the plate near the tubes and the tubes is rough toenhance the adhesion of the gums to the tubes. Preferably the tube isnot straight but also has external protrusions or at least one circularwider ring to improve the adhesion of the gums and prevent the slippingof the gums when the device is distracted.

Another important feature of the device is its increase in verticaldimension along the distraction process. If the device is enlarged alongthe distraction process the device can reach the teeth of the opposingjaw and the process of distraction is stopped. If A is the distancebetween the most upper point of the device and the bone before thedistraction process and B is the distance between the most upper pointof the device and the bone after the distraction process and C is thedistraction of the device meaning the path of the plate then B ispreferably less than A+C. Preferably A=B as it is in the device of FIG.13. The height of the device of FIG. 13B is the same as the height ofthe device of FIG. 13A and it is the height of the device along thedistraction process. The height of the device of FIG. 13C after thereplacement of the elevating mechanism is even smaller.

In another preferred embodiment the elevating mechanism can be based onadding components above the dental implants instead of screwing. Forexample it is possible to screw to the dental implant a primary abutmentthat its lower region having a screw to fit the internal threads of thedental implant and its upper region having internal threads. To thisprimary abutment it is possible now to connect secondary abutments. Thesecondary abutment has on its lower region a screw to fit the internalthreads of the abutment and on its upper region internal threads as itis for the primary abutment. In this design it is possible to screw thesecondary abutment to the primary abutment or to a secondary abutment.Each time a secondary abutment is screwed to the previous abutment and asealing screw is screwed to the most upper abutment through the rings 40of the device of FIG. 13 the plate is elevated. Preferably each abutmentis elevating the plate by 1 mm. The head of the sealing screw is widerthan the rings so the device is sealed to prevent the entrance ofinfection from the oral cavity. In the device of FIG. 10-13 it ispossible to place an elastic impression material over the protrudingelements to seal the device.

The insertion of the device can be by raising a flap, insertion of thedental implants, placement of the device and suturing the gums above thedevice. Another way to prevent suturing above the device is by incisingat the vestibulum, raising a flap and perforating the flap to insert thetubes of the device and the flap is suture above bone and not above thedevice. Preferably the device is inserted by using the tunnel technique.A subperiosteal tunnel is created along the alveolar ridge, the gums areperforated at the crest at the desired location, the plate is inserted,the implants are inserted through the tubes and the elevating mechanismis installed. In order to perforate the gums it is possible to insertsmall tubes with conical caps to the tunnel connected to a wire and topull them through the gums. It is recommended to perforate the corticalbone. This can be done through the tubes of the plate or preferablythrough the small tubes inserted to perforate the gums. While using thetunnel technique it is possible to attach a membrane to the device as itis for the device described above. If a membrane is connected to thedevice preferably the membrane is perforated at its edges to allowfixation of the membrane as described in FIG. 5A. In another preferredembodiment using the tunnel technique the tubes can be connected toplate after the insertion of the plate. Preferably the plate has threadsand the tubes are threaded to the plate through the gums. The fact thatthe plate is inserted without the tubes allows to insert the platewithout significant stretching of the gums therefore insertion issimpler and damage to the gums is prevented. It is important to verifythat the connection between the tubes and the plate is sealed andinfection can't penetrate through this connection.

The filling conduit of the devices described above for example the tubesof the plate preferably have internal threads for a sealing screw andfor the connection to a filling syringe. The filling conduit preferablyhas another sealing component preferably a valve that is open whilefilling the pouch or the space of the device and is closed otherwise.The chamber between the two sealing components the screw and the valveis preferably filled with biocompatible antiseptic material likechlorhexedine gel or calcium-hydroxide. The antiseptic material shouldbe washed out before filling and put again when the cannula is closed.The syringe to be connected to the filling conduit is preferably filledwith bone augmenting material in gelatinous consistency or suspension.The filling material can be an autograft, an allograft, a xenograft, analloplast, a cytokine, a hormone, a growth factor, a physiologicallyacceptable drug, a biological modifier, a protein, an antigen, a cellchemotaxis stimulator material, a material inducing osteogenesis, anosteoinduction material, an osteoconduction material, a bioactivematerial, a bioresorbable material, a bioabsorbable material, abiodegradable material and any combination thereof. The filling materialpreferably include materials that occupy a space in the body for atleast several months. These materials preferably encourage the tissue togrow inside the space occupied by the filling material. This is theprinciple function of most bone augmenting materials available on themarket. Preferably the bone augmenting material is resorbable. Thefilling material can be augmenting bone material available in the marketlike hydroxyapatite, bovine mineral (i.e. Bio-Oss available fromGeistlich, Swiss), demineralized frized dried bone allograft, syntheticmaterials like PLA (i.e. FisioGraft from Ghimas) or suspension of bovinemineral in a liquid medium like PepGen 15 Flow from Ceramed. The fillingmaterial can be also fully or partially not bioresorbable if theprocedure is done only for aesthetic reason and implants are not goingto be inserted, for example crystal hydroxyapetit.

The filling material can include therapeutic materials and can includeself-expanding materials from the list mentioned above. Many of the boneaugmenting materials have the tendency to expand when getting wet byhydration.

The foregoing procedure has been described in terms of the mandible. Ofcourse, the same procedure can also be applied to reconstruction of themaxilla and other bones and for other tissues in the body.

In another preferred embodiment a similar device can be inserted intothe lips or breast filled with material that stimulate fat tissueregeneration or connective tissue regeneration resulting in enlargementof these organs. In these embodiments the pouch is preferably perforatedand it is filled with fat cells. The fat cells can be sucked fromanother region in the body were there is excess of fat or can be stemcells. The perforations are to allow rapid vascularization of the cells.The advantage of using fat cells over silicon gels is that there are noside effects of silicon. Fat injection is a known treatment that has twobasic drawbacks. One is that it is difficult to control the shape of thefat after injections resulting in not smooth appearance. The secondproblem is that fat injection has a tendency to have calcified regionsin them that resembles calicifications in breast cancer. The treatmentwith fat injections demands many injections all around the breast inorder to control the shape of the breast. Women that have received thiskind of treatment needs many biopsies because the calcifications allaround the breast look like cancer in mammography. In the presentinvention the fat is placed in one known place and the shape can becontrolled. Several successive introductions of fat cells will act as atissue expander. The use of resorbable perforated tissue expander willeliminate the need for a second surgery for taking out the tissueexpander. The pouch can be filled with slowly bioresorbable collagen.The perforations in the pouch are at the range of several hundreds ofmicrons preferably of 0.5 mm to allow tissue to enter inside the pouch.

Another preferred embodiment is to use a device that the filling elementfor example the cannula is made of two parts one is external made ofnonresorbable material and the second is internal made of bioresorbablematerial. The border between the two is preferably the slot. In thisdevice it is easy to take the nonresorbable part out by twisting thecannula and leaving the bioresorbable inside the body.

Another preferred embodiment of the device and method is boneaugmentation of the maxillary sinus called also sinus lift. Thisprocedure is done when the alveolar ridge beneath the maxillary sinus istoo short—less then 8 mm height. The floor of the sinus is lined with adelicate membrane called the Schneiderian membrane. Beneath the floor ofthe sinus there is the short alveolar ridge covered by the gums.

The inflatable device like the device of FIG. 3 can be inserted throughthe alveolar ridge to the sinus below the Schneiderian membrane orthrough the buccal wall of the maxillary sinus to be lateral and belowthe Schneiderian membrane. The perforated side of the device is facingthe bone of the floor of the sinus and the non-perforated region or theless perforated region is facing the Schneiderian membrane andpreferably the opening in the wall of the sinus. When the pouch isfilled with bone augmenting material the Schneiderian membrane is raisedand the bone augmenting material is in contact with the bone.

In another preferred embodiment the filling conduit is made from abio-sissipative cloth like material which is pushed inside the sinusafter the filling of the pouch.

The pouch of the device is preferably made of collagen or otherBioresorbable material and the cannula is preferably a hollow dentalimplant. The device has preferably two sealing components a screw and avalve. The pouch can be fully or partially packed inside the hollowimplant.

In another preferred embodiment the upper region of the pouch isconnected to resorbable cord. The cord is protruding through theosteotomy and can be slowly allowed to get inside the sinus. This methodallows to control the vertical enlargement of the pouch. If the pouch isnot allowed to grow vertically it will grow horizontally therefore theraising of the Schneiderian membrane will be more efficient and safe.

In another preferred embodiment the lower region of the pouch can beeasily detached from the upper region. The two regions can be connectedby a suture that can be pulled out. The lower region can be connected tothe filling conduit so when the filling conduit is taken out the lowerregion is coming out also leaving the bone augmenting material withdirect contact with the floor of the sinus. In this embodiment the lowerregion can be not resorbable.

In another embodiment the filling conduit is a hollow bone implant thatcan be left in place and serve in the future to support a dentalprosthesis.

In another preferred device illustrated in FIG. 17 the pouch is in theshape of a coil 51. This configuration is particularly useful for thefixation of tissues especially of a fracture 50 in a bone 49. This pouchis to be placed around the fracture and it is connected to a catheter 53(filling conduit) made of bioresorbable material that has abioresorbable valve 55. The external part of the catheter 52 is made ofnonresorbable material and has a sealing component a screw 54. There isa slot 56 in the catheter, which is the braking point for taking thecatheter out after finishing all the filling of the pouch. The devicecan be made from different kinds of bioabsorbable materials as describedbefore.

The filling of the pouch is with a biocompatible material that sets andbecomes rigid inside the tissue. After the material has set the bonefragments near the fracture are fixated. Preferably the biocompatiblefilling material is a bioresorbable material that contains materialsassisting in the process of bone healing like bone cements available onthe market today, for example Skeletal Repair System (SRS) from Noriancompany, Healos from Orquest company, OsteoGenics and Orthovita'sOrthocomp from Howmedical Leibinger company.

This procedure assists in shaping the bone cement and prevents itsmigration from the site of application. The coiled pouch has preferablyperforated region in the internal aspect of the pouch facing the boneand less perforated or non perforated region facing the surroundingtissues. The perforated inner region is designed to allow some minorleakage of the cement under pressure to come in contact and adhere tothe bone so after the cement is set the bone fragments are fixated.There is one mass of rigid cement connecting the bone fragments throughthe internal space of the device. This unique feature is distinguishingthe present inflatable device from all prior art inflatable deviceswhich prevent the formation of a continues mass from the internal aspectof the device to the surrounding tissues and the mechanical connectionbetween two tissues like bone fragments. The external region can be alsoperforated but preferably the external region is less perforated toprevent leakage of the cement under pressure but to allow nutrition,blood supply and tissue ingrowth. If the cement is not Bioresorbable theexternal region is preferably not perforated.

In another preferred embodiment the inflatable element can be used incementoplastia. The device is inserted into a bone cavity like a bonecyst or a bone that suffers from osteoporosis. A bone cyst is apathologic phenomena that a cavity is created inside the bone. Sometimesthe cyst contains liquid and is surrounded by a membrane. The cyst has atendency to grow resulting in thinning of the walls of the bone aroundthe cyst that leads to pathologic fractures. Filling the inflatableelement with a bone augmenting material can lead to healing of the cyst.Bone augmenting materials are materials that occupy a space in the bodyfor several months and encourage the bone to grow inside this space andreplace the bone augmenting material. In a preferred embodiment thefilling bone augmenting material is a bone cement that sets inside theinflatable element. Filling of the cyst with a hard material strengthensthe bone and reduces the risk of pathologic fracture, which is the maincomplication in bone cysts and osteoporosis. It is also possible to fillthe cyst with the bone cement without the use of the inflatable elementbut then the cement can leak outside the bone and can penetrate intoblood vessels and nerves. In another preferred embodiment the inflatableelement can be configured to allow direct contact between thesurrounding tissue and the filling material. In a preferred embodimentthe inflatable element is perforated with small holes that allow for alittle amount of the bone cement to traverse the wall of the inflatableelement and touch the bone. In this embodiment the chance of majorleaking and entrance into blood vessels is reduced and the fillingmaterial is immediately touching the bone and starts its activity. Inanother preferred embodiment the inflatable element is made from atleast two areas one which is perforated, to be faced against the boneand a second area, which is not perforated, to be faced against othertissues like blood vessels and nerves. This embodiment is particularlyuseful for vertebroplasty and kyphoplasty. In these procedures a bonecement is inserted into a crushed vertebra. The cement is connecting thelower segment and the upper segment of the crushed vertebra so theycannot move against each other. When the bone segments stop moving thepain is significantly relieved and healing is faster. The problem withthese procedures is that the cement can leak inside the spinal cord andblood vessels. By using an inflatable element which has one region,which is not perforated, that faces the spinal cord and another region,which is, perforated that faces the bone segments the vertebroplasty canbe done safely. In kyphoplasty the bone segments are displaced to theiroriginal position before the crushing of the vertebra, by balloons andafterwards the bone cement is inserted. In the preferred embodimentdescribed above kyphoplasty can be done also with no need for anotherballoon to displace the bone fragments. The inflatable element as beingfilled with the bone cement is displacing the bone fragments. This makesthe procedure shorter simpler and safer. FIG. 14 illustrates a crushedvertebra 180. FIG. 15 illustrates a longitudinal section of the vertebrarevealing the inflatable device after its insertion inside the crushedvertebra. The vertebra can be reamed before the insertion to facilitatethe insertion. The inflatable pouch has perforated regions 182 facingthe upper and lower regions and a sealed region 183 facing thehorizontal plane protecting the spinal cord and the surrounding bloodvessel. FIG. 16 illustrates the device in an horizontal section throughthe vertebra The inflatable element can be made from non-resorbablematerials since it has a perforated area. In a preferred embodiment theinflatable element is made at least in part from bio-dissipativematerial. The principal function is to allow contact between the fillingmaterial and the surrounding tissue. Contact can be achieved by using aperforated inflatable element or by using a bio-dissipative material aspart of the inflatable element. These procedures can be done between anytwo bone fragments. The inflatable element is place between the bonefragments and/or around them so the perforated region is facing the bonefragments and the non-perforated region is facing the surroundingtissues. The device can be inserted inside bone cavities created bymalignant metastases. In these case the cortex of the cavity is manytimes destroyed so cementoplastia is contraindicated because of the riskof cement leakage. Using the perforated inflatable device with bonecement can prevent the leakage, strengthen the bone and reduce the painassociated with this pathology. The pore size of the inflatable elementshould be fitted to the cement consistency. In a preferred embodimentthe pore size is designed to control the leakage by controlling thepressure. In a preferred embodiment the inflatable element can haveseveral sizes of pores and by using a cement in a known consistency itis possible to control by the pressure of the cement when the cement isleaking through the large pores and when from the smaller pores. Inanother preferred embodiment monitoring the pressure can show whenleaking is started. When leaking is started although cement is insertedthe pressure is not rising proportionally. When the surgeon is gettingthis signal he can stop injecting the cement therefore the risk fordamaging leakage is significantly reduced. This monitoring and stoppingthe injection can be done automaticly using an automatic injectingmachine that is monitoring the pressure inside the syringe andprogrammed to stop when the pressure is not rising proportionally to theinjection. For kyphoplasty the device should have pore size and cementconsistency to allow pressure in the range of 200-360 PSI. In thispressure the bone fragment can be displaced. As the bone fragments aredisplaced there will be a decrease in the pressure. The surgeon bymonitoring the vertebra by X-Ray can identify if the decreased pressureis because the vertebra is opened and to continue the injection or thedecreased pressure is because of leakage and to stop the injection ofthe cement.

In another embodiment the inflatable device can be placed between twovertebras in cases of damage to the disc. Inflation of the device candisplace the vertebras and the cement leaking through the perforatedregions will fixate the vertebras in their new position. For this spinalfusion preferably the upper and lower region are perforated to allowleakage of the cement under pressure and the region facing thehorizontal plane prevent leakage towards the spine and the bloodvessels.

The inflatable element is preferably configured to stabilize the bonefragments. In one embodiment the shape of the inflatable is a coil likein FIG. 17 but it can be also like a double walled sleeve placed so thebone fragments are inside the sleeve or in the shape of a double walledsheet that can be placed around the bone fragments. The bone fragmentsare attached to the cement that is leaking through the little holes andthe shape of the cement after setting is fixating the bone fragments andstrengthen the fracture region. The size of the holes in the inflatableelement should be compatible with the filling material. The holes shouldallow a minor leakage and direct contact between the leaking material tothe material inside the device. The leakage must be possible only forless then 2 mm from the device when there is pressure that is sufficientto displace the bone fragments. Preferably only wetting of the externalsurface of the pouch is allowed. The contact between the material insideand outside the device improves the stabilization and prevent migrationof the filling material.

In another embodiment the device can be used for treatment of fracturesof long bones internally. FIG. 18 illustrates a fracture like thefracture of FIG. 17. The inflatable perforated pouch 185 is insertedinside the bone after preparing a cavity in the bone below the fracture50 and across the fracture to reach the bone above the fracture. Afterthe cement is injected through the filling conduit 56 and some minorleakage of the cement through the holes the bone fragments are fixated.If there is significant damage to the cortical bone the pouch caninclude a sealed region 186 to prevent leakage of the cement. Thefilling of the pouch under pressure can align the bone fragments.

In another preferred embodiment the perforated inflatable pouch can beused to treat avascular necrosis of the femoral head or fractures of theneck of the femur or for prevention of fractures. FIG. 19 illustrates ahip with avascular necrosis of the femoral head 190 and fracture of theneck of the femur 191. FIG. 20 illustrates the pouch 193 inside the boneafter preparing the cavity. The pouch has rounded region 195 to fit thefemoral head and an elongated region 196 to fit the neck. If thefracture is involved with significant damage to the cortical plate thepouch preferably includes a less perforated region 197 to be placedagainst the fracture to prevent leakage. The preferred design of thedevice is an elongated pouch which is perforated to allow contactbetween the cement and the surrounding bone. The size of pores are ofthe size 0.3-2 mm. The pouch has a non perforated ring approximately atthe middle of the pouch surrounding the pouch and splitting the deviceinto two parts one perforated pouch distal to the ring and oneperforated pouch proximal to the ring. The ring can be part of thedevice or can be connected over the pouch. The ring can be nonperforated or preferably perforated with small holes. The small holesallow tissue ingrowth but prevent leakage of the cement. The size of thepores are preferably 30-250 micron. Preferably in all the embodiments toallow precise placement of the less perforated region it should bedistinguished in X-Ray from the perforated region. This can be achievedby adding a radiopaque material like barium to the non perforatedregion.

The device can be used for preventing fractures in patients withadvanced osteoporosis. In these cases the device is inserted inside thehip before the fracture occures and strengthen the bone by the cement.

In another preferred embodiment the novel device can be used for spinalfusion. FIG. 21 illustrates a longitudinal inflatable pouch 210 insertedthrough two adjacent vertebras 211 and the deteriorated disc 212 betweenthem. The cavity for the device is created first coming from below. Theentrance to the body can be from anterior or from posterior. After thecavity is prepared the device is inserted and filled with the cement. Asthe cement sets the vertebras are fixated leading to spinal fusion. In apreferred embodiment the pouch is perforated to allow some degree ofcement leakage to achieve improved stabilization. Preferably the pouchhas a non perforated region in the middle at the region between thevertebras to prevent leakage of the cement. The pouch and the cement canbe Bioresorbable leading to bone tissue ingrowth inside the space of theinflatable pouch.

The perforated pouch allowing the cement to leak can be used in otherfractures like tibial plateau fracture, distal radius, long bonefractures, elbow etc'.

In another preferred embodiment the device can be used in jointreplacement procedures. In some of these procedures a longitudinalcavity is created inside the bone before the artificial joint iscemented inside the bone. In some cases a distal opening is created inthe distal region of the bone to facilitate the creation of the cavity.In order to achieve good stabilization the cement has to be pressurizedinside the bone before insertion of the stem of the prosthetic joint. Inmany case this procedure is associated with leakage of cement or fatthat can cause pulmonary embolism. The cement can also migrate along thebone or through the distal opening. In order to overcome this problemcement restrictors or plugs are inserted inside the bone. In the novelmethod illustrated in FIG. 22A after the cavity 200 in the bone 201 iscreated the inflatable element 202 is inserted inside the cavity. Theinflatable element 202 is preferably in the shape of an elongated narrowpouch. The walls 203 of this pouch are perforated to allow minor leakageof cement under pressure to allow the entrance of cement inside thewalls of the bone. This pouch preferably has one region 204 that is notperforated to prevent leakage of the cement. The non perforated region204 is preferably located in the distal region of the pouch facing thedistal opening 205 and the distal region of the cavity 206. After theinsertion of the pouch the pouch is filled with cement under pressureand the prosthetic joint illustrated in FIG. 22B is inserted inside thepouch, which is inside the bone cavity. The excess of cement will moveproximally so the surgeon can see and take it away. The pouch preventsthe leakage in other directions except for minor leakage to touch andpenetrate the bone walls. The non perforated region 204 function as thecement restrictor. The use of a soft pliable material as the cementrestrictor eliminates the need to have many sizes of restrictors and theneed to fit them precisely inside the bone.

Another property of the device is to control the width of the cementlayer. The ideal width is about 1 mm. If the cement mantle is too narrowcracks can be developed leading to loosening of the artificial joint.The novel pouch preferably has several small regions 207 along thesurface of the pouch that are about 1 mm width. These regions preventthe stem from touching the bone and take care that the width of thecement mantle is about 1 mm. The dimension of these regions parallel tothe plane of the pouch are preferably less that 1 mm in order not toreduce the contact of the cement and the bone. The pouch can be fully orpartially Bioresorbable as it is the case in all the embodimentsdescribed above. The pouch is preferably made from materials that canstrengthen the cement or materials that can be chemically connected tothe cement. In another preferred embodiment the pores in the pouch canbe with different sizes. The pores in the distal region are larger andbecame gradually smaller towards the mesial region from which theartificial joint is inserted. Gradual change of the pore size cancontrol the path of the cement leakage from the pouch. At the beginningthe cement will leak at the distal region 206 and as the pressure isrising the cement will leak more proximally. This process will eliminateair capture in the cement mantle.

In another embodiment the device can be used to allow selective releaseof drugs. The inflatable pouch can be inserted between two tissues sothe perforated region is facing one tissue and the non perforated regionis facing the other tissue. When the medication is injected inside thepouch the medication is leaking through the perforated region andinfluence one tissue and not the other tissue. This embodiment is ofparticular use for the use of toxic medications for malignant tissues.The device allows the direct contact between the malignant tissue andthe drug while preventing contact with the surrounding healthy tissues.The device can be in the shape of a double walled sleeve, the internalwall of the sleeve is perforated and the external wall is not. Thedevice is placed to surround the tissue to be treated. When themedications are inserted they leak through the internal wall towards thetreated tissue and the other tissues are protected from the influence ofthe toxic drug. In these embodiment the pore size can be smaller thensize of the pores in the embodiments above. The pore sizes are to becompatible with the drug.

In all the embodiments that describe an inflatable container having atleast one penetrable or perforated region and one less penetrable orsealed region there can be several embodiments as regard the stiffnessof each region. In one preferred embodiment the less penetrable regionis stiffer than the penetrable region in order to allow control over theshape of the device when inflated. In another preferred embodiment bothregions have substantially the same stiffness and therefore thesurrounding tissue is dictating the shape the device will have afterinflating. In another preferred embodiment the less penetrable or sealedregion is less stiff than the penetrable region so the less penetrableregion is in close contact with the bone and assuring the discontinuityof the bone is more protected from leakage. In the preferred embodimentof the device inside the vertebra the sealed circumferential region isless stiff than the rest of the device so the fracture zone is moreprotected.

Although the present invention has been described and illustrated in thecontext of certain preferred embodiments, it will be understood thatmodifications may be made without departing from the spirit of theinvention.

1. A method for treating bone having regions of discontinuity of thecortical bone comprising: inserting inside said bone an expandablecontainer and filling said container with a bone filler; said containerhas at least one first type region which is penetrable so as to allowthe release of said filler outside said container and at least onesecond type region which is less penetrable than said first type region;said second type region is placed towards said discontinuity of saidcortical bone.
 2. The method of claim 1, wherein said second type regionprevents the release of said filler outside said container
 3. The methodof claim 2, wherein said bone filler sets inside said bone after saidfilling.
 4. The method of claim 2, wherein said bone is a fracturedbone.
 5. The method of claim 4, wherein said second region is placedtowards the fracture line.
 6. The method of claim 4, wherein said boneis a vertebra.
 7. The method of claim 2, where said container has morethan one first type region which are separated by a second type region.8. The method of claim 2, wherein said filling displaces at least partof said bone.
 9. The method of claim 2, wherein said first type regionis a perforated region.
 10. The method of claim 2, wherein the pressureof said filling is strong enough to force some of the filler to get outof said container and to be in contact with said bone.
 11. The method ofclaim 4, wherein said container is stabilizing said fractured bone. 12.The method of claim 2, wherein the pressure of said filling is monitoredto know when said filler is released outside said container.
 13. Themethod of claim 4, wherein said container is inserted from one side ofsaid fracture through the fracture zone to the other side of saidfracture.
 14. The method of claim 2, wherein said bone is weak and saidfilling is inserted to prevent pathologic fracture of said bone.
 15. Themethod of claim 2, wherein said container is at least partiallybio-dissipative.
 16. The method of claim 4, wherein said fillingrealigns the segments of said fractured bone.
 17. The method of claim 2,wherein said container is connecting two vertebras.
 18. The method ofclaim 17, wherein at least part of said second type region is locatedbetween said vertebras.
 19. The method of claim 2, wherein said fillingmaterial includes a therapeutic drug.
 20. The method of claim 2, whereinsaid second type region is forming a circumferential band and said bandis less stiff than said first type region.
 21. The method of claim 3,wherein said filling material is a bio-dissipative material.